Full Press Release Details
Liquidia Corporation Reports First Quarter
2023 Financial Results and Provides Corporate Update
MORRISVILLE, N.C., May 4, 2023 - Liquidia
Corporation (NASDAQ: LQDA) (Liquidia or the Company) today reported financial results for the first quarter ended March 31, 2023.
The Company will host a webcast at 8:30 a.m. ET to discuss the financial results and provide a corporate update.
Roger Jeffs, Liquidia's Chief Executive Officer, said: "We
have heard from the physician community about the increasing demand for inhaled treprostinil to treat both pulmonary arterial hypertension
(PAH) and pulmonary hypertension with interstitial lung disease (PH-ILD). With specific regard to PH-ILD, it is clear that the need for
inhaled products to treat this previously underdiagnosed and untreated population will significantly surpass that of PAH. Based on conversations
with physicians, we believe that patients with PH-ILD, who commonly suffer from lung restriction and impaired respiratory effort, may
benefit from an inhaled formulation of treprostinil enabled by PRINT Technology and administered with a low-resistance dry powder inhaler.
This enthusiastic feedback from physicians continues to strengthen our commitment to bring YUTREPIATM (treprostinil) inhalation
powder to patients as quickly as possible."
Secured access to additional capital with revenue interest financing.
In January, HealthCare Royalty (HCRx) agreed to provide Liquidia an aggregate of up to $100 million upon certain events. To date,
HCRx has funded $32.5 million, of which $22.2 million was used to repay the then existing debt obligations to Silicon Valley Bank (SVB),
with excess proceeds of approximately $9.6 million funded to the Company after deduction of transaction costs. Liquidia may receive three
additional tranches of funding: $7.5 million to support any acquisition of rights to a clinical stage or commercial stage biopharmaceutical
product to diagnose, prevent, or treat pulmonary hypertension; $35 million upon the earlier of regulatory approval of YUTREPIA or a favorable
resolution of the ongoing patent litigation with United Therapeutics Corporation (UTC); and $25 million to be drawn upon the mutual agreement
of the parties. In exchange for the total investment, HCRx will receive a tiered royalty on net revenue generated by YUTREPIA and other
products marketed by Liquidia. The specific tiered royalty rates range between 0.36% to 10.0%, depending upon the total amount advanced
to Liquidia and achievement of certain annual net sales thresholds. HCRx will also receive certain fixed quarterly payments. The aggregate
payments to HCRx are capped at 175% of the total amounts advanced by HCRx, with the potential for a true-up payment to be made by Liquidia
if HCRx's internal rate of return is less than 18% on the date the cap is reached.
Advanced appeals of legal rulings in Hatch-Waxman and PTAB litigation.
On May 3, 2023, the Company presented oral arguments to the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) in
the appeal of the decision of the District Court in the Hatch-Waxman litigation initiated by UTC. UTC is appealing the District Court's
ruling related to U.S. Patent No. 9,593,066 (the 066 Patent) which found five of the six asserted claims of the '066 Patent
are invalid and that the remaining asserted claim is not infringed by Liquidia. Liquidia is appealing the District Court's decision
with respect to U.S. Patent No. 10,716,793 (the 793 Patent) which found that all of the claims of the 793 Patent were
valid and infringed by Liquidia based on the arguments that were presented by Liquidia in the Hatch-Waxman Litigation.
Concurrently, in April 2023, UTC initiated an appeal to the Federal
Circuit of the decision by the Patent Trial and Appeal Board (PTAB) to invalidate the 793 patent. The PTAB found in July 2022
that all claims of the 793 Patent are unpatentable based on obviousness. In February 2023, the PTAB reaffirmed that decision
when it denied UTC's request for a rehearing. Should the Federal Circuit affirm the PTAB's decision, the PTAB's decision
would override any finding in the Hatch-Waxman litigation that Liquidia has breached any valid claims of the 793 Patent.
Liquidia continues to anticipate that it will reach final legal resolution
in late 2023 or the first half of 2024.
Quarter 2023 Financial Results
totaled $94.4 million as of March 31, 2023. During the three months ended March 31, 2023, the Company received $31.8 million
net proceeds from the revenue interest financing agreement net of costs, of which $22.2 million was used to repay the Amended and Restated
Loan and Security Agreement with SVB (the A&R SVB LSA) entered into in January 2022.
was $4.5 million for the three months ended March 31, 2023, compared to $3.5 million for the three months ended March 31, 2022.
Revenue related primarily to the Promotion Agreement. The increase of $1.0 million was primarily due to increased quantities and favorable
gross-to-net rebate adjustments.
of revenue was $0.7 million for both the three months ended March 31, 2023 and 2022. Cost of revenue related to the Promotion
Agreement as noted above.
and development expenses were $5.3 million for the three months ended March 31, 2023, compared with $4.7 million for the three
months ended March 31, 2022. The increase of $0.6 million or 12% was primarily due to a $0.5 million increase in consulting and personnel
expenses in preparation for the potential commercialization of YUTREPIA.
and administrative expenses were $7.8 million for the three months ended March 31, 2023, compared with $12.5 million for the
three months ended March 31, 2022. The decrease of $4.7 million or 38% was primarily due to a $4.0 million decrease in legal fees
related to ongoing YUTREPIA-related litigation and a $1.8 million decrease in stock-based compensation expense driven by an option modification
charge recorded in 2022. These decreases were offset by a $1.1 million increase in commercial, marketing, and personnel expenses in preparation
for the potential commercialization of YUTREPIA.
Other expenses, net was
$2.5 million for the three months ended March 31, 2023, compared with $1.5 million for the three months ended March 31, 2022.
The three months ended March 31, 2023 included a $2.3 million loss on extinguishment of debt related to repayment of the A&R
SVB LSA in January 2023. The three months ended March 31, 2022 included a $1.0 million loss on extinguishment of debt related
to the refinance of long-term debt with SVB during January 2022.
Net loss for the three months ended
March 31, 2023, was $11.7 million, or $0.18 per basic and diluted share, compared to a net loss of $15.9 million, or $0.30 per basic
and diluted share, for the three months ended March 31, 2022.
About YUTREPIA (treprostinil) inhalation
YUTREPIA is an investigational, inhaled dry
powder formulation of treprostinil delivered through a convenient, low-resistance, palm-sized device. On November 5, 2021, the FDA
issued a tentative approval for YUTREPIA, which is indicated for the treatment of pulmonary arterial hypertension (PAH) to improve exercise
ability in adult patients with New York Heart Association (NYHA) Functional Class II-III symptoms. The FDA has confirmed that YUTREPIA
may add the indication to treat pulmonary hypertension with interstitial lung disease (PH-ILD) without additional clinical studies. YUTREPIA
was designed using Liquidia's PRINT technology, which enables the development of drug particles that are precise
and uniform in size, shape, and composition, and that are engineered for optimal deposition in the lung following oral inhalation. Liquidia
has completed INSPIRE, or Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil, an open-label, multi-center
phase 3 clinical study of YUTREPIA in patients diagnosed with PAH who are na ve to inhaled treprostinil or who are transitioning
from Tyvaso (nebulized treprostinil). YUTREPIA was previously referred to as LIQ861 in investigational studies.
About Treprostinil Injection
Treprostinil Injection is the first-to-file,
fully substitutable generic treprostinil for parenteral administration. Treprostinil Injection contains the same active ingredient, same
strengths, same dosage form and same inactive ingredients as Remodulin (treprostinil) and is offered to patients and
physicians with the same level of service and support, but at a lower price than the branded drug. Liquidia PAH promotes the appropriate
use of Treprostinil Injection for the treatment of PAH in the United States in partnership with its commercial partner, who holds the
Abbreviated New Drug Application (ANDA) with the FDA.
About Liquidia Corporation
Liquidia Corporation is a biopharmaceutical
company focused on the development and commercialization of products in pulmonary hypertension and other applications of its PRINT
Technology. The company operates through its two wholly owned subsidiaries, Liquidia Technologies, Inc. and Liquidia PAH,
LLC. Liquidia Technologies has developed YUTREPIA (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension
(PAH). Liquidia PAH provides the commercialization for pharmaceutical products to treat pulmonary disease, such as generic Treprostinil
Injection. For more information, please visit www.liquidia.com.
Cautionary Statements Regarding Forward-Looking
This press release may include forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release
other than statements of historical facts, including statements regarding our future results of operations and financial position, our
strategic and financial initiatives, our business strategy and plans and our objectives for future operations, are forward-looking statements.
Such forward-looking statements, including statements regarding clinical trials, clinical studies and other clinical work (including the
funding therefor, anticipated patient enrollment, safety data, study data, trial outcomes, timing or associated costs), regulatory applications
and related submission contents and timelines, including the potential for final FDA approval of the NDA for YUTREPIA, the timeline or
outcome related to appeals arising from our patent litigation in the U.S. District Court for the District of Delaware or inter partes
review proceedings conducted at the PTAB, the issuance of patents by the USPTO and our ability to execute on our strategic or financial
initiatives, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein.